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Human medicine European public assessment report (EPAR): Eladynos
abaloparatide, Osteoporosis, Postmenopausal; Osteoporosis
, Authorised, Last updated: 22/12/2022
osteosarcoma (a type of bone cancer) or in patients who have bone cancer or cancer that has spread to the bones … osteosarcoma (a type of bone cancer) or in patients who have bone cancer or cancer that has spread to the bones … -
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Human medicine European public assessment report (EPAR): Mycapssa
Octreotide acetate, Acromegaly
Date of authorisation: 02/12/2022,
, Authorised, Last updated: 22/12/2022
pituitary adenoma (a non-cancerous tumour in the pituitary gland … pituitary adenoma (a non-cancerous tumour in the pituitary … -
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Human medicine European public assessment report (EPAR): Locametz
gozetotide, Radionuclide Imaging
Date of authorisation: 09/12/2022, Authorised, Last updated: 21/12/2022used in adults with prostate cancer to detect prostate cancer cells with a protein called … find out whether prostate cancer has spread to lymph nodes … find out whether prostate cancer has returned in patients … -
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Human medicine European public assessment report (EPAR): Pluvicto
lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 09/12/2022,, Authorised, Last updated: 21/12/2022
a medicine used to treat cancer of the prostate (a gland … system). It is used when the cancer is metastatic (spreading … hormone testosterone), and the cancer cells have a protein called … -
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Human medicine European public assessment report (EPAR): VidPrevtyn Beta
SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain), COVID-19 virus infection
Date of authorisation: 10/11/2022,, Authorised, Last updated: 30/11/2022
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Human medicine European public assessment report (EPAR): Sugammadex Amomed (updated)
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 10/01/2023,
, Authorised, Last updated: 13/01/2023
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Human medicine European public assessment report (EPAR): Pirfenidone Viatris (updated)
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 10/01/2023,, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Qdenga (updated)
Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated, Dengue virus, serotype 2, live, attenuated, Dengue
Date of authorisation: 05/12/2022,, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Pemetrexed Baxter (updated)
pemetrexed disodium heptahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 09/12/2022,, Authorised, Last updated: 19/01/2023
to treat two types of lung cancer: malignant pleural mesothelioma … malignant pleural mesothelioma (a cancer of the lining of the lungs … chemotherapy before and whose cancer cannot be removed by surgery … -
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Human medicine European public assessment report (EPAR): Livmarli
Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022,, , 
, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Ebvallo (updated)
Tabelecleucel, Lymphoproliferative Disorders
Date of authorisation: 16/12/2022,, , , Authorised, Last updated: 12/01/2023
marrow-transplantation, develop a blood cancer called Epstein-Barr virus … these cells that can lead to cancer. Ebvallo is used in patients … experienced in the treatment of cancer; it should be given in a controlled … -
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Teva
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 12/12/2022,, Authorised, Last updated: 21/12/2022
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Human medicine European public assessment report (EPAR): Tezspire
tezepelumab, Asthma
Date of authorisation: 19/09/2022,, Revision: 1, Authorised, Last updated: 09/11/2022
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Human medicine European public assessment report (EPAR): Ximluci
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 09/11/2022,, 
, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Teriparatide Sun
teriparatide, Osteoporosis; Osteoporosis, Postmenopausal
Date of authorisation: 18/11/2022, Authorised, Last updated: 12/12/2022as Paget’s disease, bone cancer or bone metastases cancer that has spread to the bone … Paget’s disease, bone cancer or bone metastases cancer that has spread to the bone … -
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Human medicine European public assessment report (EPAR): Teriflunomide Mylan (updated)
Teriflunomide, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 09/11/2022,, Revision: 1, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Teriflunomide Accord
Teriflunomide, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 09/11/2022,, Authorised, Last updated: 14/11/2022
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Human medicine European public assessment report (EPAR): Sorafenib Accord
Sorafenib tosilate, Carcinoma, Hepatocellular; Carcinoma, Renal Cell
Date of authorisation: 09/11/2022,, Authorised, Last updated: 25/11/2022
Sorafenib Accord is a cancer medicine used to treat patients … carcinoma (a type of liver cancer); advanced renal cell carcinoma … carcinoma (a type of kidney cancer) when … -
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Human medicine European public assessment report (EPAR): Zynlonta (updated)
loncastuximab tesirine, Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Date of authorisation: 20/12/2022,, 
, Authorised, Last updated: 26/01/2023
lymphoma (a type of blood cancer): diffuse large B-cell lymphoma … with experience in using cancer medicines. Zynlonta is given … white blood cell) have become cancerous. The The substance responsible … -
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Human medicine European public assessment report (EPAR): Pyrukynd
mitapivat sulfate, Genetic Diseases, Inborn; Anemia, Hemolytic
Date of authorisation: 09/11/2022,, , Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Livtencity (updated)
Maribavir, Cytomegalovirus Infections
Date of authorisation: 09/11/2022,, , Revision: 1, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Enjaymo
sutimlimab, Hemolysis; Anemia, Hemolytic, Autoimmune
Date of authorisation: 15/11/2022,, , Authorised, Last updated: 17/11/2022
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Human medicine European public assessment report (EPAR): Beyfortus (updated)
nirsevimab,
Date of authorisation: 31/10/2022,, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Accord
metformin hydrochloride, sitagliptin hydrochloride monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 22/07/2022,, Revision: 1, Authorised, Last updated: 01/09/2022
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Human medicine European public assessment report (EPAR): Zokinvy
Lonafarnib, Progeria; Laminopathies
Date of authorisation: 18/07/2022,, , , Authorised, Last updated: 01/08/2022